Kornimate/medical-research-clean huggingface dataset:
endovascular vs surgical arteriovenous fistula outcomes

Conditions: Dialysis Fistula Creation; Endo-vascular AVFs

Summary: arteriovenous fistulas (avfs) are the preferred type of vascular access for dialysis, but many of them fail to mature. there are two techniques of creating avfs either the traditional way with surgery( surgical avfs) or novel per-cutaneous technique endo- avfs. investigators will pilot an randomized clinical trial of endo-avfs and surgical avfs at university of alabama at birmingham to determine the feasibility of patient recruitment, randomization, and retention. this pilot study will set the stage for a full-scale randomized clinical trial in future.

arteriovenous fistulas (avfs) are the preferred type of vascular access for dialysis, but many of them fail to mature. despite concerted efforts to improve surgical avf outcomes during the past 20 years, many new avfs fail to mature, even after interventions to salvage them (assisted maturation). postoperative ultrasounds of immature avfs frequently demonstrate decreased flow with narrowing at the anastomosis . surgically created avfs typically have a 90o angle at the anastomosis, yet computational fluid dynamics suggest that an anastomotic angle \<30o improves the flow hemodynamics. therefore, there has been great interest in novel avf technologies to limit vascular injury and improve flow dynamics and maturation rates. the new technology evaluated herein (endovascular avf (endo-avf) has the potential to achieve these goals and reduce the cost of vascular access care. endo-avf, a novel per-cutaneous technique of avf creation, was approved by the fda in 2018, and has been used in u.s. hemodialysis patients . in contrast to the surgical technique (the current standard), this non-surgical approach (1) minimizes vascular injury at the time of avf creation and (2) creates a channel between the artery and vein with an angle approaching 0o. these two features provide a scientific rationale for superior maturation compared with that of surgical avf investigators will perform a single-center, prospective pilot randomized clinical trial. investigators will recruit 80 patients who have advanced chronic kidney disease or on hemodialysis with a catheter ,who there pre- operative ultrasound showed they are eligible to surgical or endo-vascular avf. participants will be randomized to one of two groups: an surgical avf intervention group that will undergo a routine surgical fistula creation, or an endo-vascular avf intervention group will undergo per-cutaneous fistula creation . participants will be followed for 2 years.

Eligibility criteria:
inclusion criteria: * study will include participants who are 18 years and older who are scheduled to have an avf * preoperative ultrasound showed feasibility to have an endo-vascular avf vs surgical upper arm avf exclusion criteria: * age below 18 years * participants eligible for low forearm avf ( radio-cephalic)
efficacy of proprioceptive neuromuscular facilitation in pain relief

Conditions: Migraine Disorders

Summary: the purpose of this study is to determine whether the contract-relax technique of proprioceptive neuromuscular facilitation, and the static stretching exercise are effective in reducing the frequency, intensity and duration of headache and in improving the perception of quality of life in women with migraine.

this is an randomized clinical trial, double blind, comparing two interventions in women with migraine, whose diagnosis was confirmed by a neurologist.

Eligibility criteria:
inclusion criteria: * age between 18and 40 years * clinical diagnosis of migraine * participants with at least one day with acute migraine per month, with attacks lasting 4-72 hours. exclusion criteria: * obesity type i, ii or iii, according to the classification of body mass index. * pregnancy, lactation or both. * presence of meningitis, demyelinating diseases, cerebral aneurysm, intracranial hypertension, myopathies, myelopathy, fibromyalgia, symptomatic neck disc herniation, rheumatoid arthritis and history of tumors in the brain or spine. * participants who performed other manual therapeutic interventions or other physical therapy modalities in the head or neck during the survey period. * participants who have daily prophylactic medication for migraine.

Keywords: migraine disorders muscle stretching exercises
study of medical ultrasound for rhizarthrosis

Conditions: Rhizarthrosis

Summary: it was never investigated which preservative non-invasive treatments are superior to treat rhizarthrosis. this randomized study compares the effect of 1. hand therapy vs. 2. therapeutic ultrasound vs. 3. hand therapy plus therapeutic ultrasound in the treatment of rhizarthrosis.


Eligibility criteria:
inclusion criteria: * male and female patients aged 40 to 90 years * pain intensity in the region of the thumb base in pain phases ≥ 40 mm on the vas of 0 to 100 mm (relative to the last 24 hours) * complaints for at least 3 months * x-ray stadium eaton i-iv at least once secured exclusion criteria: * history of surgery on the affected hand, wrist or forearm * planned surgery in the next 8 months * anticoagulation (marcumar, heparin) * haemophilia, v. willebrandt jürgens syndrome, thrombocytopathy and other blood anomalies * acute pain medication (\<7 days) * systemic medication with corticoids or immunosuppressants * intraarterticular injections or rso within the last 3 months * pregnancy, lactation * insulin-dependent type i diabetes mellitus * significant cognitive impairment * clinically relevant or progressive disease (e.g., liver, kidney, cardiovascular system, respiratory tract, vascular system, brain, metabolism, thyroid) that could affect the course of the study * malignant disease * simultaneous participation in an interventional study or participation in an interventional study in the last two months before study inclusion * clinically relevant addiction or substance abuse disorder (defined as alcohol, drug and drug abuse) * insufficient mental possibility of cooperation * therapy with oral anticoagulants (e.g., marcumar) * suspected lack of compliance * medical, psychiatric or other conditions that restrict the patient's following abilities: to interpret the study information, to give informed consent, to adhere to the rules of the protocol, or to complete the study

Keywords: degeneration trapeziometacarpal osteoarthritis basal joint arthritis arthrosis hand thumb
repeated cross sectional surveillance study to determine the influenza vaccination rates in german participants

Conditions: Influenza Immunization

Summary: real-time monitoring of vaccination rates for germany is unavailable, and up-to-date data publication is delayed, which makes it challenging to develop effective public health strategies to increase vaccination coverage. this study aims to address the gap by assessing current influenza vaccination rates, particularly among those aged 60 and older, to inform public health interventions and encourage healthcare providers to recommend influenza vaccination more proactively. the primary objective of this study is to determine the influenza vaccination rates in the german population during the current respiratory season. the study will focus on: 1. assessing the vaccination rates among the two main age groups 18 years of age through and including 59 years of age and 60 years of age (inclusive) and older 2. assessing the vaccination rate among individuals with risk-based vaccination recommendation according to standing committee on vaccination (ständige impfkommission) (stiko) the study will target a disproportionate sample of the german population regarding age: 30% aged 18 years of age through and including 59 year of age and 70% aged 60 years of age (inclusive) and older. within these age groups, the study targets a representative distribution regarding gender and region. this study is conducted as an online survey that will either be self-completed by the respondents (cawi) or completed via an interviewer for a subgroup of respondents aged 70+ (cati). the survey is estimated to last 10 minutes and will comprise of closed-ended questions only (i.e., respondents will not have the possibility to add any free-text). the survey will be conducted in german. the panelists will be divided into strata based on demographic variables like gender and region. within each stratum, participants will be randomly selected to participate in the survey.


Eligibility criteria:
inclusion criteria: * reside in germany at the time of survey completion * be at least 18 years old at the time of survey completion. * agree with privacy policy and ae (adverse event) reporting requirements before proceeding with the survey. * read and agree to the icf (informed consent form) by ticking a box before proceeding with the survey or telephone interview. exclusion criteria: * participation in the study (= completed the survey or telephone interview) in a previous wave of the current season. * living in nursing home note: the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Keywords: seasonal influenza influenza vaccination rates
lifestyle changes in older adults with metabolic syndrome and tinnitus

Conditions: Tinnitus; Metabolic Syndrome X; Obesity; Elderly; Weight Loss

Summary: the problem of tinnitus (subjective type) is prevalent in obese older adults with different diseases such as metabolic syndrome. the changes of lifestyle are very important to lose weight, improve tinnitus and metabolic syndrome

sixty older adults (with metabolic syndrome with chronic subjective tinnitus) with obesity were selected in a equal random manner to be classified into the first group that administered changes in their lifestyle (exercise applied on treadmill and low caloric diet) for twelve successive weeks and second group that was not administered lifestyle changes

Eligibility criteria:
inclusion criteria: * obese person (class one obesity) * patients with metabolic syndrome * patients with chronic subjective tinnitus (bilateral complaint from more than six months). * older adults aging 65 years and more * both sexes will be included exclusion criteria: * respiratory insult * cardiac insult * liver insult * kidney insult * lower limb insult * neurological insult
physical and mental assessment of older patients with newly diagnosed acute myeloid leukemia

Conditions: Cognitive/Functional Effects; Depression; Leukemia

Summary: rationale: learning about physical ability and mental function over time in older patients with acute myeloid leukemia may help doctors learn about the long-term effects of treatment and plan the best treatment. purpose: this clinical trial is assessing physical and mental status in older patients with newly diagnosed acute myeloid leukemia.

objectives: primary * test the feasibility of pre-treatment, bedside assessment of functional and cognitive status in older adults with newly diagnosed acute myeloid leukemia (aml). secondary * obtain preliminary data regarding the predictive value of pre-treatment, bedside assessment of functional and cognitive status on overall survival, length of hospitalization and early death. outline: this is a prospective study. at baseline, patients complete questionnaires including the vulnerable elders survey (functional status), the mini-mental status exam (cognition), and the center for epidemiologic studies-depression. patients also undergo physical function testing via the short physical performance battery and hand grip strength. further information parameters are obtained by periodic medical chart reviews. patients are followed every 3 months for up to 2 years.

Eligibility criteria:
disease characteristics: * pathologically confirmed newly diagnosed acute myeloid leukemia * planned induction chemotherapy * inpatient status patient characteristics: * no requirement for intensive care unit support prior concurrent therapy: * see disease characteristics * no prior therapy for acute myeloid leukemia

Keywords: depression cognitive/functional effects untreated adult acute myeloid leukemia adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22)
a study to compare to pk characteristics and safety profiles between ad-227 and co-administration of ad-227a and ad-227b

Conditions: Primary Hypertension

Summary: primary endpoint of this study is to evaluate the pharmacokinetic characteristics of ad-227 in healthy subjects.


Eligibility criteria:
inclusion criteria: * body weight equal to or greater than 50kg (female 45kg) and body mass index (bmi) between 18.0 kg/m2 and 30.0 kg/m2 at the time of screening visit * the age equal to or greater than 19 in healthy volunteers at the time of screening visit exclusion criteria: * participation in another clinical study with an investigational drug within the 6 months from scheduled first administration * other exclusions applied
study of alfimeprase's ability to dissolve blood clots in the leg and help prevent the need for surgery

Conditions: Arterial Occlusive Diseases

Summary: the purpose of this study is to directly compare the safety and efficacy of intra-thrombus alfimeprase 0.3 mg/kg with placebo in acute peripheral arterial occlusion (pao) as measured by a 30 day open vascular free surgery rate.

there is an unmet medical need to improve thrombolytic therapy in acute peripheral arterial occlusion (pao). currently used plasminogen activators can result in increased circulating levels of plasmin that result in a systemic "lytic state" that does not distinguish between physiologic and pathologic thrombosis. in general, mean plasminogen activator infusion durations of greater than 24 hours in order to achieve successful thrombolysis are problematic in a disease where delayed restoration of arterial flow can lead to irreversible ischemic damage. a direct thrombolytic agent like alfimeprase, with a rapid mechanism of action and a potentially safer bleeding risk profile, could facilitate a rapid restoration of arterial flow and avoidance of open vascular surgery.

Eligibility criteria:
inclusion criteria: * age 18 or older * arteriographically confirmed acute pao of the lower extremity with onset of symptoms within 14 days prior to randomization * acute index limb ischemia classified as svs/iscvs class i or iia caused by occlusion of a native artery and/or bypass graft (vein or prosthetic). only class i subjects with abrupt onset of ischemic rest pain or abrupt onset/progression of lifestyle-limiting claudication are eligible * acute pao with a need for urgent surgical intervention to restore arterial blood flow in the event of unsuccessful thrombolytic therapy * available for follow-up assessments exclusion criteria: * contraindication to systemic anticoagulation * history of endovascular procedure or open vascular surgery on the index limb within the past 30 days * history of significant acute or chronic kidney disease that would preclude contrast angiography * known allergy to contrast agents * history of heparin induced thrombocytopenia * participation in any study of an investigational device, medication, biologic, or other agent within 30 days prior to randomization * any thrombolytic therapy within 5 days prior to randomization * past participation in any alfimeprase trial * pregnant, lactating, or actively menstruating women or women of childbearing potential who are not using adequate contraceptive precautions * investigator inability to advance guidewire through index occlusion * any other subject feature that in the opinion of the investigator should preclude study participation

Keywords: pao acute peripheral arterial occlusion thrombolysis blood clot leg attack alfimeprase thrombus embolism thromboembolism claudication thrombolytic thrombosis plasminogen activator arterial flow
treatment of newly diagnosed elderly patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: in multiple myeloma, combination chemotherapy with melphalan plus prednisone has been used since the 1960s and is regarded as the standard of care in elderly patients. we assess whether the addition of thalidomide to this combination or adapted high-dose chemotherapy, using a melphalan 100 mg/m2 -based regimen, would improve survival.

trial design this multicenter, randomized, controlled trial is conducted by the french myeloma intergroup(ifm) in elderly patients with previously untreated multiple myeloma. the primary objectives of the study are to compare the efficacy and safety of mp with mp-thalidomide or with mel100 (intermediate-dose melphalan 100 mg/m2 - based treatment). the secondary objective is to compare the efficacy of mp-thalidomide vs mel100.

Eligibility criteria:
inclusion criteria: * stage ii or iii multiple myeloma according to durie and salmon criteria. * patients between 65 and 75 years of age * previously untreated patients exclusion criteria: * prior history of another neoplasm (except basocellular cutaneous or cervical epithelioma) * primary or associated amyloidosis * world health organisation performance index of at least 3 * significant renal insufficiency with creatinine serum levels of 5.0 mg per deciliter or more * cardiac or hepatic dysfunction * cerebral circulatory insufficiency * absolute contraindication to corticosteroids * peripheral neuropathy * hiv or hepatitis b or c positivity * patients who had geographic, social or psychological conditions which might prevent adequate follow-up

Keywords: multiple myeloma elderly patients thalidomide autologous transplantation
a ccta image assisted triage software for the assessment of patients with suspected coronary artery disease

Conditions: Coronary Heart Disease

Summary: the goal of this clinical trail is to evaluate the effectiveness and accuracy of the ccta image assisted triage software(deepvessel® cardisight, keya medical.) for the triage of patients with suspected coronary artery disease.

the ccta images collected by each center within a certain period of time would be screened, desensitized, and then evaluated by the software and independent expert group respectively, to evaluate the effectiveness and accuracy of the coronary ct angiography image stenosis assisted triage software developed by koyal medical technology co. experiment group: evaluated by the software independent expert group: evaluated by experts (≥5 years of ccta experience required)

Eligibility criteria:
inclusion criteria: 1. ccta images acquired by ct detectors need to meet the following requirements: * check modal = ct * number of detector rows ≥ 64 rows * layer thickness ≤1mm * layer spacing ≤1mm * pixel pitch ≤ 0.5mm * ball tube voltage ≥ 70kv * number of layers ≥ 100 layers 2. ccta image quality score ≥ 3 (5-point likert scale). exclusion criteria: 1. severe coronary artery calcification, which in the judgment of readers affects the stenosis adjudicator; 2. previous percutaneous coronary intervention (pci) or coronary artery bypass grafting (cabg); 3. congenital anomalies of coronary artery origin or other malformations; 4. coronary artery occlusive lesions; 5. implantation of the pacemaker, internal defibrillator electrode, or prosthetic heart valve.
paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin for recurrent or metastatic squamous cell carcinoma of the head and neck

Conditions: Squamous Cell Carcinoma Of The Head And Neck

Summary: the purpose of this single arm, phase ⅱ clinical trail is to determine the safety and efficacy of paclitaxel (albumin bound),bleomycin and cisplatin or carboplatin in the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck


Eligibility criteria:
inclusion criteria: * biopsy proved squamous cell carcinoma of the head and neck; * stage ivc according to union for international cancer control (uicc) edition viii, or recurrent disease after chemotherapy and/or radiotherapy; * 18 years or older; without other malignancy; * proper functioning of the major organs. exclusion criteria: * allergic to paclitaxel (albumin bound) or bleomycin or cisplatin or carboplatin ; * female within gestation period or lactation; * patients received drug of other clinical trial within 3 months
differences in morbidity between a necessity endotracheal suctioning protocol versus a routine endotracheal suctioning

Conditions: Hypoxemia; Arrhythmias; Cardiac Arrest; Ventilator Associated Pneumonia

Summary: morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.

endotracheal aspiration is a very useful procedure. it has several adverse events every time that aspiration is practiced. this trials wants to identify which protocol (necessity versus routine) could be better to practice in pediatrics intensive care unit with less risk.

Eligibility criteria:
inclusion criteria: * children older than 1 month until 14 years old requiring orotracheal intubation exclusion criteria: * high frequency ventilation mode

Keywords: unplanned extubation length of stay in picu length of mechanical ventilation
effectiveness of picture exchange communication system on gingival health of children with autism spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: the picture exchange communication system (pecs) is a communication system for children with autism spectrum disorders (asd). the aim of this study was to assess the effect of a pecs-based tooth-brushing program on gingival health in children with asd and assess parents' perception of pecs. this was a prospective interventional study. using pecs as a pictures/cards series showing a structured tooth-brushing method, 37 children with asd (31 males, 6 females) (average age 9.49±4.10, 4-16 years) and their parents/caregivers were trained on tooth-brushing twice, two weeks apart. data collected after examinations (baseline, 3, 6-months) included gingival and plaque indices (gi, pi) and two questionnaires (baseline, 6-months) for demographic data and parents' perception of pecs including: difficulty rating (easy, hard, very hard) and pecs usefulness.

the need for improved oral hygiene routines in individuals with autism spectrum disorders (asd) has been documented in many reports. the picture exchange communication system (pecs), which is a series of pictures that show a structured method and technique for teeth brushing, was chosen for this study since it is a proven communication system for children with autism spectrum disorders (asd). the aim of the study was to assess the effect of a pecs-based tooth-brushing program on gingival health in children with asd and assess parents' perception of pecs. this was a prospective interventional study. using pecs as a pictures/cards series showing a structured tooth-brushing method, 37 children with asd (31 males, 6 females) (average age 9.49±4.10, 4-16 years) and their parents/caregivers were trained on tooth-brushing twice, two weeks apart. the pictures were placed in the bathroom, at home and/or at the autism center. data collected after examinations (baseline, 3, 6-months) included gingival and plaque indices (gi, pi) and two questionnaires (baseline, 6-months) for demographic data and parents' perception of pecs including: difficulty rating (easy, hard, very hard) and whether they found pecs useful in teaching their children how to brush their teeth (yes or no).

Eligibility criteria:
inclusion criteria: * children diagnosed with asd. * age between 4 and 18 years old. exclusion criteria: * children unable to cooperate for data collection (poor behavior during dental examination).

Keywords: autism spectrum disorder picture exchange communication system (pecs) tooth-brushing program gingival index plaque index